SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
PURSUANT
TO SECTION 13 OR 15(d) OF THE
SECURITIES
EXCHANGE ACT OF 1934
July
28, 2010 |
Date of report (Date of earliest event reported) |
SurModics, Inc. |
(Exact Name of Registrant as Specified in its Charter) |
Minnesota |
0-23837 |
41-1356149 |
||
(State of Incorporation)
|
(Commission File Number)
|
(I.R.S. Employer Identification No.) |
9924 West 74th Street Eden Prairie, Minnesota |
55344 |
|
(Address of Principal Executive Offices) | (Zip Code) |
(952) 829-2700 |
(Registrant’s Telephone Number, Including Area Code) |
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2):
⃞ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
⃞ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
⃞ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
⃞ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item 2.02. Results of Operations And Financial Condition.
On July 28, 2010, SurModics, Inc. issued a press release announcing the
results for the quarter ended June 30, 2010. A copy of the full text of
the press release is furnished as Exhibit 99.1 to this report.
Item
9.01. Financial Statements and Exhibits.
(d) Exhibits.
Exhibit Number |
Description | ||
99.1 | Press Release dated July 28, 2010. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
SURMODICS, INC. |
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Date: | July 28, 2010 |
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/s/ Philip D. Ankeny |
Philip D. Ankeny |
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Interim Chief Executive Officer, Senior |
|||
Vice President and Chief Financial Officer |
EXHIBIT INDEX
Exhibit | |
Number |
Description |
99.1 |
Press Release dated July 28, 2010 |
Exhibit 99.1
SurModics Reports Third Quarter 2010 Results
EDEN PRAIRIE, Minn.--(BUSINESS WIRE)--July 28, 2010--SurModics, Inc. (Nasdaq: SRDX), a leading provider of drug delivery and surface modification technologies to the healthcare industry, today reported financial results for the third quarter ended June 30, 2010.
Third Quarter Summary:
“SurModics’ third quarter financial results were mixed. Royalties and license fees continue to benefit from our diverse portfolio of licensed customers. Product sales were particularly strong, posting a new quarterly record. However, our quarterly revenue performance was adversely impacted by decreased R&D revenue compared with the second quarter, reflecting a period of relatively slower activity that occurs periodically during our long-range customer development programs,” said Phil Ankeny, interim CEO, senior VP and CFO. “On the earnings front, third quarter results were negatively impacted by asset and investment impairment charges. Excluding these non-cash charges, however, non-GAAP EPS was $0.11, compared with non-GAAP EPS of $0.10 in the second quarter.”
Sequential Comparison
On a GAAP basis, revenue for the third
quarter of fiscal 2010 was $18.6 million, compared with $18.4 million in
the second quarter. The Company reported operating income of $2.2
million, compared with an operating loss of $1.0 million in the second
quarter; a net loss of $0.9 million, compared with a net loss of $0.4
million in the second quarter; and diluted loss per share of ($0.05),
compared with diluted loss per share of ($0.02) in the second quarter of
fiscal 2010.
Results for the third quarter of fiscal 2010 included a $2.6 million non-cash investment impairment charge in connection with the Company’s portfolio of strategic investments, as well as a $0.2 million non-cash asset impairment charge associated with fixed assets. Excluding these charges, non-GAAP results for the third quarter were as follows: operating income was $2.4 million, in line with the second quarter; net income was $1.8 million, compared with $1.7 million in the second quarter; and diluted earnings per share was $0.11, compared with $0.10 in the second quarter.
Year-over-Year Comparison
On a GAAP basis, revenue for the
third quarter of fiscal 2010 was $18.6 million, compared with $18.2
million in the year earlier period. The Company reported operating
income of $2.2 million, compared with $4.7 million in the prior-year
period; net loss of $0.9 million, compared with net income of $3.5
million in the same period last year; and diluted loss per share of
($0.05), compared with diluted earnings per share of $0.20 in the third
quarter of fiscal 2009.
Other Highlights
SurModics’ pipeline continues to represent
important potential. The Company added five new licenses in the third
quarter, for a fiscal year-to-date total of 16 against its goal of
signing 18 new licenses in fiscal 2010. SurModics’ customers launched
two new product classes in the marketplace during the quarter, for a
fiscal year-to-date total of 7 against its goal of 10 launches in fiscal
2010. As of June 30, 2010, SurModics’ customers had 104 licensed product
classes generating royalty revenue, compared with 105 in the prior-year
period; the total number of licensed product classes not yet launched
was 110, up from 105 in the prior-year period; and major non-licensed
opportunities totaled 72, compared with 87 a year ago. In total,
SurModics now has a portfolio of 182 potential commercial products in
development across multiple clinical indications and technology
platforms.
Cash and investments at the end of the third quarter totaled $54.8 million, compared with $51.8 million at the end of the second quarter. Operating cash flow for the quarter was $4.4 million, compared with $7.9 million in the third quarter of fiscal 2009; for the first nine months of fiscal year 2010, operating cash flow was $16.7 million, as the Company continues to generate cash.
“SurModics has preserved its excellent financial condition through continued generation of strong operating cash flow and by maintaining a healthy balance sheet with zero debt,” continued Ankeny. “Given our optimism in the Company’s potential for long-term growth, we will continue to deploy our capital in a manner that maximizes our ability to better serve our customers, support our strategic initiatives and add value for our shareholders.”
Live Webcast
SurModics will host a webcast at 5:00 p.m.
ET (4:00 p.m. CT) today to discuss the quarterly results. To access the
webcast, go to the investor relations portion of the Company’s website
at www.surmodics.com, and click on the third quarter webcast
icon. If you do not have access to the Internet and want to listen to
the audio by phone, dial 866-328-4270. A replay of the third quarter
conference call will be available by dialing 800-406-7325 and entering
conference call ID 4330268. The audio replay will be available beginning
at 7:00 p.m. CT on Wednesday, July 28, until 7:00 p.m. CT on Wednesday,
August 4.
About SurModics, Inc.
SurModics’ vision is to extend
and improve the lives of patients through technology innovation. The
Company partners with the world’s foremost medical device,
pharmaceutical and life science companies to develop and commercialize
innovative products that result in improved diagnosis and treatment for
patients. Core offerings include: drug delivery technologies (coatings,
microparticles, nanoparticles, and implants); surface modification
coating technologies that impart lubricity, prohealing, and
biocompatibility capabilities; and components for in vitro diagnostic
test kits and specialized surfaces for cell culture and microarrays.
SurModics is headquartered in Eden Prairie, Minnesota and its SurModics
Pharmaceuticals subsidiary is located in Birmingham, Alabama. For more
information about the Company, visit www.surmodics.com. The
content of SurModics’ website is not part of this release or part of any
filings the Company makes with the SEC.
Safe Harbor for Forward-Looking Statements
This press
release contains forward-looking statements. Statements that are not
historical or current facts, including statements about beliefs and
expectations, such as our expectations about our pipeline, our ability
to achieve our fiscal 2010 company goals, our optimism for the long
term, and our continued use of our balance sheet and investment in our
business, are forward-looking statements. Forward-looking statements
involve inherent risks and uncertainties, and important factors could
cause actual results to differ materially from those anticipated,
including the following: (1) our reliance on third parties (including
our customers and licensees) and their failure to successfully develop,
obtain regulatory approval for, market and sell products incorporating
our technologies may adversely affect our business operations, our
ability to realize the full potential of our pipeline, and our ability
to achieve our fiscal 2010 corporate goals; (2) costs or difficulties
relating to the integration of the businesses of SurModics
Pharmaceuticals and BioFX Laboratories, and the drug delivery assets and
collaborative programs acquired from PR Pharmaceuticals, Inc., with
SurModics’ business may be greater than expected and may adversely
affect the Company’s results of operations and financial condition; (3)
developments in the regulatory environment, as well as market and
economic conditions, may adversely affect our business operations and
profitability; and (4) other factors identified under “Risk Factors” in
Part I, Item 1A of our Annual Report on Form 10-K for the fiscal year
ended September 30, 2009, and updated in our subsequent reports filed
with the SEC. These reports are available in the Investors section of
our website at www.surmodics.com and at the SEC website at www.sec.gov.
Forward-looking statements speak only as of the date they are made, and
we undertake no obligation to update them in light of new information or
future events.
Use of Non-GAAP Financial Information
In addition to
reporting financial results in accordance with generally accepted
accounting principles, or GAAP, SurModics is reporting non-GAAP
financial results including non-GAAP revenue, non-GAAP income from
operations, non-GAAP net income and non-GAAP diluted net income per
share. We believe that these non-GAAP measures provide meaningful
insight into our operating performance excluding certain event-specific
charges and as it relates to our accounting treatment for contracts with
significant deferred revenue, such as the agreement with Genentech, and
provide an alternative perspective of our results of operations. We
believe that our non-GAAP recognition of up-front license fees, which
are recognized as deferred revenue under GAAP, provides a relevant
perspective of how our activities in a period may generate cash. We use
these non-GAAP measures to assess our operating performance and as an
input in determining payouts under our executive compensation programs.
We believe that presentation of these non-GAAP measures allows investors
to review our results of operations from the same perspective as
management and our board of directors. We believe these non-GAAP
measures facilitate investors’ analysis and comparisons of our current
results of operations and provide insight into the prospects of our
future performance. We also believe that the non-GAAP measures are
useful to investors because they provide supplemental information that
research analysts frequently use. The method we use to produce non-GAAP
results is not in accordance with GAAP and may differ from the methods
used by other companies. These non-GAAP results should not be regarded
as a substitute for corresponding GAAP measures, but instead should be
utilized as a supplemental measure of operating performance in
evaluating our business. Non-GAAP measures have limitations in that they
do not reflect certain items that may have a material impact on our
reported financial results. As such, these non-GAAP measures should be
viewed in conjunction with both our financial statements prepared in
accordance with GAAP and the reconciliation of the supplemental non-GAAP
financial measures to the comparable GAAP results provided for certain
periods presented, which are attached to this release.
SurModics, Inc. and Subsidiaries |
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Condensed Consolidated Statements of Operations |
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(In thousands, except per share data) |
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Three Months Ended | Nine Months Ended | |||||||||||||||
June 30, | June 30, | |||||||||||||||
2010 | 2009 | 2010 | 2009 | |||||||||||||
(Unaudited) |
(Unaudited) |
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Revenue | ||||||||||||||||
Royalties and license fees | $ | 9,356 | $ | 8,200 | $ | 26,333 | $ | 65,999 | ||||||||
Product sales | 5,769 | 5,130 | 15,586 | 13,762 | ||||||||||||
Research and development | 3,483 | 4,856 | 12,430 | 22,566 | ||||||||||||
Total revenue | 18,608 | 18,186 | 54,349 | 102,327 | ||||||||||||
Operating costs and expenses | ||||||||||||||||
Product costs | 2,388 | 1,988 | 6,820 | 5,341 | ||||||||||||
Customer research and development | 4,642 | 3,184 | 12,748 | 10,257 | ||||||||||||
Other research and development | 4,223 | 4,443 | 13,507 | 15,207 | ||||||||||||
Selling, general and administrative | 4,944 | 3,910 | 13,667 | 12,996 | ||||||||||||
Purchased in-process research and development | — | — | — | 3,200 | ||||||||||||
Restructuring charges | — | — | 1,306 | 1,798 | ||||||||||||
Asset impairment charges | 191 | — | 2,265 | — | ||||||||||||
Total operating costs and expenses | 16,388 | 13,525 | 50,313 | 48,799 | ||||||||||||
Income from operations | 2,220 | 4,661 | 4,036 | 53,528 | ||||||||||||
Other (loss) income | ||||||||||||||||
Investment income | 539 | 794 | 1,120 | 1,796 | ||||||||||||
Impairment loss on investments | (2,577 | ) | — | (2,577 | ) | — | ||||||||||
Other (loss) income | (2,038 | ) | 794 | (1,457 | ) | 1,796 | ||||||||||
Income before income taxes | 182 | 5,455 | 2,579 | 55,324 | ||||||||||||
Income tax provision | (1,098 | ) | (1,916 | ) | (2,005 | ) | (20,484 | ) | ||||||||
Net (loss) income | $ | (916 | ) | $ | 3,539 | $ | 574 | $ | 34,840 | |||||||
Basic net (loss) income per share | $ | (0.05 | ) | $ | 0.20 | $ | 0.03 | $ | 2.00 | |||||||
Diluted net (loss) income per share | $ | (0.05 | ) | $ | 0.20 | $ | 0.03 | $ | 1.99 | |||||||
Weighted average shares outstanding | ||||||||||||||||
Basic | 17,360 | 17,356 | 17,373 | 17,458 | ||||||||||||
Diluted | 17,360 | 17,379 | 17,385 | 17,492 | ||||||||||||
SurModics, Inc. and Subsidiaries |
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Condensed Consolidated Balance Sheets |
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(In thousands) |
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June 30, | September 30, | ||||||
2010 | 2009 | ||||||
Assets | (Unaudited) | ||||||
Current assets | |||||||
Cash and short-term investments | $ | 21,718 | $ | 20,568 | |||
Accounts receivable | 10,752 | 11,320 | |||||
Inventories | 3,506 | 3,330 | |||||
Other current assets | 4,861 | 1,796 | |||||
Total current assets | 40,837 | 37,014 | |||||
Property and equipment, net | 66,964 | 66,915 | |||||
Long-term investments | 33,033 | 27,300 | |||||
Other assets | 50,027 | 54,333 | |||||
Total assets | $ | 190,861 | $ | 185,562 | |||
Liabilities and Stockholders’ Equity | |||||||
Current liabilities | $ | 7,907 | $ | 7,984 | |||
Other liabilities | 8,329 | 5,206 | |||||
Total stockholders’ equity | 174,625 | 172,372 | |||||
Total liabilities and stockholders’ equity | $ | 190,861 | $ | 185,562 | |||
SurModics, Inc. and Subsidiaries |
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Condensed Consolidated Statements of Cash Flows |
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(In thousands) |
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Nine Months Ended | ||||||||
June 30, | ||||||||
2010 | 2009 | |||||||
Operating Activities: | (Unaudited) | |||||||
Net income | $ | 574 | $ | 34,840 | ||||
Adjustment to reconcile net income to net cash provided by operating activities: | ||||||||
Depreciation and amortization | 5,950 | 4,352 | ||||||
Stock-based compensation | 4,192 | 4,988 | ||||||
Purchased in-process research and development | — | 3,200 | ||||||
Restructuring charges | 1,306 | 1,798 | ||||||
Deferred taxes | 990 | 8,616 | ||||||
Asset impairment charges | 2,265 | — | ||||||
Impairment loss on investments | 2,577 | — | ||||||
Net other operating activities | (268 | ) | (104 | ) | ||||
Change in operating assets and liabilities: | ||||||||
Accounts receivable | 568 | 2,675 | ||||||
Accounts payable and accrued liabilities | (775 | ) | (3,261 | ) | ||||
Income taxes | (2,796 | ) | 3,302 | |||||
Deferred revenue | 2,881 | (35,816 | ) | |||||
Net change in other operating assets and liabilities | (751 | ) | 179 | |||||
Net cash provided by operating activities | 16,713 | 24,769 | ||||||
Investing Activities: | ||||||||
Net purchases of property and equipment | (7,196 | ) | (21,660 | ) | ||||
Business acquisitions, net of cash acquired | (750 | ) | (8,585 | ) | ||||
Other investing activities | (10,325 | ) | 11,122 | |||||
Net cash used in provided by investing activities | (18,271 | ) | (19,123 | ) | ||||
Financing Activities: | ||||||||
Issuance of common stock | 892 | 655 | ||||||
Repurchase of common stock | (2,032 | ) | (14,998 | ) | ||||
Purchase of common stock to fund employee taxes | (393 | ) | (457 | ) | ||||
Net other financing activities | 72 | (478 | ) | |||||
Net cash used in financing activities | (1,461 | ) | (15,278 | ) | ||||
Net change in cash and cash equivalents | (3,019 | ) | (9,632 | ) | ||||
Cash and Cash equivalents | ||||||||
Beginning of period | 11,636 | 15,376 | ||||||
End of period | $ | 8,617 | $ | 5,744 | ||||
SurModics, Inc. and Subsidiaries |
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Supplemental Non-GAAP Information |
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For the Three Months Ended June 30, 2010 |
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(In thousands, except per share data) |
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(Unaudited) |
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Long-term Agreement |
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As |
Revenue |
Billed |
Other |
Adjusted |
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Revenue: | ||||||||||||||||||
Royalties and license fees | $9,356 | $(47 | ) | (3) | $-- | (4) | $9,309 | |||||||||||
Product sales | 5,769 | 5,769 | ||||||||||||||||
Research and development | 3,483 | 3,483 | ||||||||||||||||
Total revenue | $18,608 | $(47 | ) | $-- | $18,561 | |||||||||||||
Income from operations | $2,220 | $(47 | ) | $-- | $191 | (5) | $2,364 | |||||||||||
$(916 | ) | $(25 | ) | $-- | $1,827 | |||||||||||||
Net (loss) income | (6) | (6) | $2,768 | (7) | ||||||||||||||
Diluted net (loss) income per share (8) | $(0.05 | ) | $0.11 | |||||||||||||||
Balance at |
Revenue |
Billed |
Balance at |
|||||||||||||||
Deferred revenue (9) | $3,610 | $(47 | ) | $-- | ||||||||||||||
$3,563 | ||||||||||||||||||
(1) | Reflects operating results in accordance with U.S. generally accepted accounting principles (GAAP). | |
(2) |
Adjusted Non-GAAP amounts exclude amortization of deferred license fee revenue in the period associated with the Genentech and other agreements under GAAP and include up-front license fees associated with Genentech and other agreements; and exclude the asset impairment charges of $191 and impairment loss on investments of $2,577. The Adjusted Non-GAAP effective tax rate is 37% for the period presented. | |
(3) | Reflects amortization of deferred license fee revenue for the Genentech and other agreements in accordance with GAAP for the period presented. | |
(4) | Reflects amounts billed and deferred (up-front license fees) under the Genentech and other agreements for the period presented. | |
(5) | Reflects asset impairment charges of $191. | |
(6) |
Reflects the after tax impact of the adjustments utilizing the Company’s effective tax rate for the period presented. |
|
(7) | Reflects the after tax impact of the asset impairment charges utilizing the Company’s effective tax rate. The impairment loss on investments of $2,577 does not generate a tax benefit. | |
(8) | Diluted net (loss) income per share is calculated using the diluted weighted average shares outstanding for the period presented. | |
(9) | Reflects the activity for the period presented in the deferred revenue balance sheet accounts associated with the Genentech and other agreements. |
SurModics, Inc. and Subsidiaries |
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Supplemental Non-GAAP Information |
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For the Nine Months Ended June 30, 2010 |
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(In thousands, except per share data) |
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(Unaudited) |
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Long-term Agreement |
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As |
|
Revenue |
Billed |
Other |
Adjusted |
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Revenue: | |||||||||||||||||
Royalties and license fees | $26,333 | $(137 | ) | (3) | $3,700 | (4) | $29,896 | ||||||||||
Product sales | 15,586 | 15,586 | |||||||||||||||
Research and development | 12,430 | 12,430 | |||||||||||||||
Total revenue | $54,349 | $(137 | ) | $3,700 | $57,912 | ||||||||||||
Income from operations | $4,036 | $(137 | ) | $3,700 | $3,571 | (5) | $11,170 | ||||||||||
$574 | $(84 | ) | $2,379 | $7,742 | |||||||||||||
Net income | (6) | (6) | $4,873 | (7) | |||||||||||||
Diluted net income per share (8) | $0.03 | $0.45 | |||||||||||||||
Balance at |
Revenue |
Billed |
Balance at |
||||||||||||||
Deferred revenue (9) | $-- | $(137 | ) | $3,700 | |||||||||||||
$3,563 | |||||||||||||||||
(1) | Reflects operating results in accordance with U.S. generally accepted accounting principles (GAAP). | |
(2) | Adjusted Non-GAAP amounts exclude amortization of deferred license fee revenue in the period associated with the Genentech and other agreements under GAAP and include up-front license fees associated with Genentech and other agreements; and exclude the restructuring charges of $1,306, asset impairment charges of $2,265 and impairment loss on investments of $2,577. The Adjusted Non-GAAP effective tax rate is 37% for the period presented. | |
(3) | Reflects amortization of deferred license fee revenue for the Genentech and other agreements in accordance with GAAP for the period presented. | |
(4) | Reflects amounts billed and deferred (up-front license fees) under the Genentech and other agreements for the period presented. | |
(5) | Reflects restructuring charges of $1,306 and asset impairment charges of $2,265. | |
(6) | Reflects the after tax impact of the adjustments utilizing the Company’s effective tax rate for the period presented. | |
(7) | Reflects the after tax impact of the restructuring charges and asset impairment charges utilizing the Company’s effective tax rate. The impairment loss on investments of $2,577 does not generate a tax benefit. | |
(8) | Diluted net income per share is calculated using the diluted weighted average shares outstanding for the period presented. | |
(9) | Reflects the activity for the period presented in the deferred revenue balance sheet accounts associated with the Genentech and other agreements. |
CONTACT:
SurModics, Inc.
Phil Ankeny, interim CEO, Senior VP and
CFO, 952-829-2700